Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 947ae6fe-05d9-4bcf-be73-b3e1a2c60227
Routes
ORAL TOPICAL
Published
Effective Date 2025-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (1 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-01
Description

Magnesium sulfate USP (heptahydrate) 100%

Purpose

 Saline laxative

Medication Information

Purpose

 Saline laxative

Description

Magnesium sulfate USP (heptahydrate) 100%

Uses
  • for relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 1/2 to 6 hours
Directions
  • do not exceed more than 2 doses per day; if necessary repeat dosage in 4 hours
age dose
 adults and children 12  years and older  2-4 level teaspoons dissolved in a full glass (8oz) of water 
 children 6 to 11 years

1-2 level teaspoons dissolved in a full glass (8oz) of water


Not recommended for children under 6 years of age.
Package Label
SIGNATURE CARE Epsom Salt
Active Ingredient

Magnesium sulfate USP (heptahydrate) 100%

Other Information
  • each teaspoon contains: magnesium 495 mg
Inactive Ingredients

None

Questions Or Comments?

For laxative or soak, call 1-877-753-3935 Monday- Friday 9AM-5PM EST

Principal Display Panel

EPSOM SALTS

Magnesium Sulfate U.S.P.

Mg SO4 + 7H2O

Soaking aid for minor sprains & bruises

Saline laxative for relief of occasional constipation

For external use as a soaking aid for minor sprains and bruises

CAUTION: IF PROMPT RELIEF IS NOT OBTAINED OR THERE IS EVIDENCE OF INFECTION. DISCONTINUE USE AND CONSULT YOUR PHYSICIAN. HOT OR WARM SOAKS SHOULD NOT BE USED BY INDIVIDUALS WITH DIABETES EXCEPT ON THE ADVISE OF A PHYSICIAN. KEEP OUT OF REACH OF CHILDREN.

STORE IN COOL DRY PLACE OUT OF DIRECT SUNLIGHT. PACKAGE SOLD BY WEIGHT NOT VOLUME. SOME SETTLING OF CONTENT MAY OCCUR DURING SHIPMENT. IF CAKING OCCURS, TAP POUCH GENTLE TO FREE GRANULES

NET WT OZ  (LB) kg

Tamper Evident Packaging: Caution: this package has been sealed for your protection. Do not use if package is open, torn or mutilated

DISTRIBUTED BY:

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

When Using This Product
  • do not use more than directed
Stop Use and Ask A Doctor If
  • you have rectal bleeding or failure to have a bowel movement after use. This may indicate a serious condition.
  • you need to use a laxative for more than 1 week
Keep Out of Reach of Children.

 In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

If Pregnancy Or Breast Feeding,

 ask a health professional before use.

Ask A Doctor Before Use If You Have
  • kidney disease
  • a magnesium restricted diet
  • stomach pain, nausea or vomiting
  • noticed a sudden change in bowel habits that lasts more than 2 weeks
Ask A Doctor Or Pharmacist Before Use If You Are

 presently taking a prescription drug.

Structured Label Content

Uses
  • for relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 1/2 to 6 hours
Purpose

 Saline laxative

Directions
  • do not exceed more than 2 doses per day; if necessary repeat dosage in 4 hours
age dose
 adults and children 12  years and older  2-4 level teaspoons dissolved in a full glass (8oz) of water 
 children 6 to 11 years

1-2 level teaspoons dissolved in a full glass (8oz) of water


Not recommended for children under 6 years of age.
Package Label
SIGNATURE CARE Epsom Salt
Active Ingredient (Active ingredient)

Magnesium sulfate USP (heptahydrate) 100%

Other Information (Other information)
  • each teaspoon contains: magnesium 495 mg
Inactive Ingredients

None

Questions Or Comments? (Questions or comments?)

For laxative or soak, call 1-877-753-3935 Monday- Friday 9AM-5PM EST

Principal Display Panel

EPSOM SALTS

Magnesium Sulfate U.S.P.

Mg SO4 + 7H2O

Soaking aid for minor sprains & bruises

Saline laxative for relief of occasional constipation

For external use as a soaking aid for minor sprains and bruises

CAUTION: IF PROMPT RELIEF IS NOT OBTAINED OR THERE IS EVIDENCE OF INFECTION. DISCONTINUE USE AND CONSULT YOUR PHYSICIAN. HOT OR WARM SOAKS SHOULD NOT BE USED BY INDIVIDUALS WITH DIABETES EXCEPT ON THE ADVISE OF A PHYSICIAN. KEEP OUT OF REACH OF CHILDREN.

STORE IN COOL DRY PLACE OUT OF DIRECT SUNLIGHT. PACKAGE SOLD BY WEIGHT NOT VOLUME. SOME SETTLING OF CONTENT MAY OCCUR DURING SHIPMENT. IF CAKING OCCURS, TAP POUCH GENTLE TO FREE GRANULES

NET WT OZ  (LB) kg

Tamper Evident Packaging: Caution: this package has been sealed for your protection. Do not use if package is open, torn or mutilated

DISTRIBUTED BY:

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

When Using This Product (When using this product)
  • do not use more than directed
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding or failure to have a bowel movement after use. This may indicate a serious condition.
  • you need to use a laxative for more than 1 week
Keep Out of Reach of Children. (Keep out of reach of children.)

 In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

If Pregnancy Or Breast Feeding, (If pregnancy or breast-feeding,)

 ask a health professional before use.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • kidney disease
  • a magnesium restricted diet
  • stomach pain, nausea or vomiting
  • noticed a sudden change in bowel habits that lasts more than 2 weeks
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

 presently taking a prescription drug.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:55.705145 · Updated: 2026-03-14T23:08:22.901159